Manual Acupuncture (MA) for Asymptomatic Hyperuricemia (HUA)
ConditionAsymptomatic Hyperuricemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenghao Tu
About this trial
Assess the effectiveness of manual acupuncture in modulating serum uric acid levels among patients diagnosed with asymptomatic hyperuricemia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
With serum uric acid (SUA) level >7 mg/dL after 1 month of a low-purine diet.
No history of gouty arthritis.
Has not received uric acid-lowering drug treatment or stopped uric acid- lowering drug treatment ≥ 12 weeks.
18.5kg/m2 ≤ body mass index (BMI) ≤ 30.0 kg/m2.
Disqualifiers
Patients with poorly controlled hypertension: systolic blood pressure (SBP) ≥ 160mmHg, diastolic blood pressure (DBP) ≥ 100 mmHg.
Patients with poorly controlled diabetes (hemoglobin A1c ≥ 8.4%).
Patients with severe liver and kidney damage: chronic kidney disease (CKD) ≥ stage 2 or a serum creatinine, urea, alanine, or aspartate aminotransferase level more than twice of the upper limit.
Patients with blood system diseases, such as acute and chronic leukemia, polycythemia, multiple myeloma, hemolytic anemia, lymphoma, or undergoing chemotherapy for multiple solid tumors.
Trial design
Design model
Parallel
Treatments tested in this trial
Manual acupuncture
DeviceAfter sterilisation, the sharp needles will be inserted into the deep tissue layers of acupoints. Acupuncturists will tried to elicit acupuncture de-qi sensation by the manual manipulation of needles. Within a 30-minute period, manual manipulation for each acupoint will last at least 10 seconds and wil repeated four times with intervals of 10-minute.
Sham acupuncture
DeviceAfter sterilisation, Streitberger placebo needles with blunt tip will be used. It can be fixed on the surface of the sham points without piercing the skin. Within a 30-minute period, each point will undergo a simulated twisting motion of the needle for at least 10 seconds, and this will be repeated four times at 10-minute intervals.
Treatment groups
260 Participants
are divided into 2 treatment groupsGroup A: Manual acupuncture groupExperimental treatment 1 intervention
Group B: Sham acupuncture groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Serum uric acid (SUA)
Changes in the SUA level after 8 weeks of treatment.
Time frame
Baseline and 8 weeks after randomization.Secondary outcomes
1
Proportion of participants with SUA ≤ 6.0 mg/dL
The proportion of participants with SUA ≤ 6.0 mg/dL after treatment.
Time frame
4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.2
Proportion of participants with SUA ≤ 7.0 mg/dL.
The proportion of participants with SUA ≤ 7.0 mg/dL after treatment.
Time frame
4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.3
Dynamic changes in the SUA level after treatment.
Time frame
Baseline, 4 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.4
The proportion of participants with gout attacks
The proportion of participants with gout attacks after randomization
Time frame
4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.Other outcomes
1
Body weight
Changes in the body weight after treatment.
Time frame
baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.2
Abdominal circumference
Changes in abdominal circumference after treatment.
Time frame
baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.3
NEO Personality Inventory-Short Form (NEO-FFI)
NEO Personality Inventory-Short Form (NEO-FFI)
Time frame
baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.4
Traditional Chinese medicine (TCM) constitution
Changes in the Traditional Chinese medicine (TCM) constitution after treatment
Time frame
baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shenghao Tu
Lead sponsor
Tongji Hospital
Sponsor institution
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Xianning Hospital of Traditional Chinese Medicine, China
Collaborator
Beijing Hospital of Traditional Chinese Medicine
Collaborator
Qianjiang Central Hospital, China
Collaborator
Hainan General Hospital
Collaborator
Yichang Central People's Hospital
Collaborator
Wuhan No.1 Hospital
Collaborator
The Second Hospital of Huangshi
Collaborator
Puyang Hospital of Traditional Chinese Medicine
Collaborator
Source ClinicalTrials.gov